AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2/3NCT05939180

VA vs DA for Newly Diagnosed Hig-risk AML

A Phase 2/3 study testing Venetoclax Oral Tablet and Daunorubicin in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Venetoclax Oral Tablet and Daunorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
2 sitesChina
Study dates
1 Apr 2024to 13 May 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Gender: female or male.
  • Age:18-64 years old.
  • Patients with newly diagnosed AML according to the WHO 2022 classification.
  • AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification.
  • Untreated AML (hydroxyurea, and low dose cytarabine with cummulative dose <1.0g are permitted).
  • ECOG: 0-2.
Show all 9Show fewer
  • Adequate liver function: Total bilirubin ≤ 1.5×upper limit of normal (ULN); aspartate aminotransferase (AST) ≤3×ULN (liver infiltration of leukemia: ≤5×ULN); alanine aminotransferase (ALT)≤3×ULN (liver infiltration of leukemia: ≤5×ULN) .
  • Adequate Renal function: Ccr (Creatinine Clearance Rate) ≥30 ml/min.
  • Be able to understand and be willing to participate in the study. Be able to provide written informed consent.

Who cannot join

  • Patients with acute promyeloid leukemia.
  • AML with central nervous system infiltration.
  • Patients diagnosed with myeloid sarcoma.
  • Patients have AML secondary to MDS and previously been treated with hypomethylating agents.
  • Patients with active infection, which is considered as uncontrollable by the investigator.
  • Patients with active hepatitis B, hepatitis C and HIV infection.
Show all 9Show fewer
  • Patients with heart failure (grade 3-4);
  • Patients who are pregnant or breastfeeding.
  • Patients who refused to be enrolled in the study. Patients who are considered as ineligible for the enrollment by the investigators.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Su-ning Chen contact

008613814881746

chensuning@sina.com

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

    Suzhou, Jiangsu, 215000

    Suning Chen, 13814881746, chensuning@sina.com

    Recruiting

  • Ethical Committee of the First Affliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Zhou-lin Lu, 13914086271

    Recruiting

Other trials in China

About this study

Official title: Study of the Efficacy and Safety of Venetoclax Plus Azacytidine Versus Daunorubicin Plus Cytarabine in Adult Acute Myeloid Leukemia (AML) Patients With Adverse Risk Features

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Read the detailed description

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Newly diagnosed AML patients with adverse risk features according to 2022 European Leukemia Net risk stratification will be enrolled. In the study, a novel second generation targeted sequencing panel for the fast screening of adverse mutations with 72-hours after the bone marrow samples will be utilized. Randomized participants will receive induction treatment . Participants will be 1:1 randomly assigned to the VA and DA groups. VA regimen comprises of azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28. DA regimen comprises of daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Being tested
Venetoclax Oral Tablet, Daunorubicin
Keywords
Adverse risk, newly diagnosed, induction therapy
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venetoclax Oral TabletDrug

    Also called venetoclax plus azacytidine

    VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.

  • DaunorubicinDrug

    Also called daunorubicin plus cytarabine

    DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Study groups in NCT05939180
Study groupRoleWhat they receive
VA regimenExperimentalVA regimen: azacytidine and venetoclax
Receives: Drug: Venetoclax Oral Tablet
DA regimenActive comparatorDA regimen: daunorubicin and cytarabine
Receives: Drug: Daunorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite complete remission (CRc) after one course of induction therapy

    Rates of complete remission plus complete remission with incomplete blood cell rates of complete remission or complete remission with incomplete marrow recovery

    Measured: From randomization to the end of the first course of induction therapy (within 28 days)

Secondary outcomes (6)

  1. DOR: duration of remission

    Time between the first remission and relapse

    Measured: 2 years

  2. EFS：event-free survival

    time from the date of enrollment to treatment failure, relapse, death from any cause or the last follow-up

    Measured: 2 years

  3. OS: overall survival

    time from the date of enrollment to death from any cause or the last follow-up

    Measured: 2 years

  4. Volume of infused blood products

    The volume of infused blood products during the induction treatment.

    Measured: Within 60 days after randomization

  5. AE

    Adverse events during the induction treatment.

    Measured: Within 60 days after randomization

  6. Composite complete remission (CRc) after two courses of induction therapy

    complete remission or complete remission with incomplete marrow recovery

    Measured: From randomization to the end one and two courses of induction therapy (within 60 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2023
  2. Study start1 Apr 2024
  3. Primary completion13 Jun 2026
  4. Study completion13 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05939180
Sponsor's protocol ID
SZ-AML03
Status last verified
Aug 2026
First submitted
3 Jul 2023
Last updated
2 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Venetoclax Oral Tablet and Daunorubicin in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital of Soochow University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Su-ning Chen (008613814881746, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite complete remission (CRc) after one course of induction therapy (time frame: From randomization to the end of the first course of induction therapy (within 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05939180.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in